- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04187118
Quality of Life in Lymphoma Patients One Year Post-chemotherapy (QUALIPSO-L)
September 18, 2023 updated by: University Hospital, Toulouse
Quality of Life in Lymphoma Patients and Cancer Care Pathway One Year Post-chemotherapy
Malignant lymphomas are considered as among the most chemo-sensitive cancers.
ML are cured in more than 85% of patient, the majority with complete response.
After this active phase of treatment, patients are in "after cancer period".
Toulouse University Hospital developed since 2006 the Ambulatory Medical Assistance for After Cancer program on lymphoma patient.
Ambulatory Medical Assistance for After Cancer is very efficient for detecting physical and psychological complications which impact quality of life.
The investigators identified 22% of lymphoma patients who had a reduced quality of life one year after the end of chemotherapy.
The present study aims to investigate the evolution of observed complications and identify cancer care pathway which decrease the quality of life reduction risk in patients one year after lymphoma chemotherapy.
Study Overview
Detailed Description
Quality of life, as well anxiety, depression, social isolation, fear of cancer recurrence, post traumatic stress, will be measured in lymphoma patients, after a first line chemotherapy.
Care cancer pathway will be also evaluated.
Self-administered questionnaires will be performed on website (www.hospitalidee.fr) after inclusion and 12 months after.
Study Type
Observational
Enrollment (Estimated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Loïc YSEBAERT, MD, PhD
- Phone Number: 561145940
- Email: ysebaert.loic@iuct-oncopole.fr
Study Contact Backup
- Name: Fabien DESPAS, Pharm, PhD
- Phone Number: 33 561145940
- Email: fabien.despas@univ-tlse3.fr
Study Locations
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-
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Toulouse, France
- Recruiting
- University Hospital Toulouse
-
Contact:
- Loic YSEBERT, MD
- Email: Ysebaert.Loic@iuct-oncopole.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with lymphoma
Description
Inclusion Criteria:
- Patients being in complete response after a first therapy for lymphoma
- Malignant lymphoma (Hodgkin or non-Hodgkin) treated by anthracyclines with a minimum of 6 cycles, followed or not by autologous hematopoietic stem cell transplantation
- Patients informed of the study and not opposed to the research
Exclusion Criteria:
- Patients under legal guardian .
- Patients unavailable to formulate non-opposition to the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lymphoma patients
Patients being in complete response after a first therapy for malignant lymphoma.
|
Quality of life one year post chemo-therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life change: Quality of Life-C30 French version
Time Frame: Change from baseline quality of life at 12 month
|
Health-related quality of life is evaluated by the use of Quality of Life-C30 French version
|
Change from baseline quality of life at 12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Loïc YSEBAERT, MD, PhD, University Hospital, Toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 28, 2020
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
November 27, 2019
First Submitted That Met QC Criteria
December 3, 2019
First Posted (Actual)
December 5, 2019
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 18, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/19/0295
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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